Electronic submissions only
From 8 August 2019 accepted the Paul Ehrlich Institut applications for approval of clinical trials (CTA ) exclusively in electronic form and to accept CTA without a paper version.
In a first phase, initial applications for clinical trials and subsequent substantial amendment will be accepted in accordance with §10 GCP-V. With immediate effect all submissions as substantial amendments, terminations, DSURs, etc. will also be accepted electronically, even if the initial applications have not been submitted electronically.
Electronic applications must be submitted via CESP. Submission via Eudralink or e-mail will not be accepted and applications submitted via these channels will be deemed not to have been submitted.
Initial applications or amendments must always be submitted in their entirety. Subsequent deliveries or additions of parts are not permitted. If, after consultation with the Paul Ehrlich Institute, Section Clinical Trials (email@example.com), they are exceptionally accepted due to special circumstances, the date of the subsequent delivery in the CESP system is considered the new application date of the entire application.
In addition to the initial application, the reply to formal letters of deficiency (validation) and the reply to the letters of the Paul Ehrlich Institute with justified objections (GNA) according to § 9 GCP-V (letter of deficiency with regard to content) will also be accepted electronically. Follow-up procedures such as amendments, terminations, DSURs, etc. are also accepted.
Applications cannot be submitted in parallel in paper form and via CESP. If both do occur, the date of the later application will be counted.
With regard to annexes and documents, the provisions of the GCP-V and the 3rd Announcement on Human Clinical Trials for the Submission of Applications for Approval of Clinical Trials continue to apply unchanged to electronic applications. In particular, the requirements for the electronic submission of applications for the approval of clinical trials of medicinal products and the structure of the contents as published on the homepage of the Paul Ehrlich Institute must be complied with.
The electronic documents must be submitted in an archive (e.g. in Zip, Winrar or 7z format) with the folder structure published on the PEI homepage. Encryption and passwords for the archive or individual files are not permitted. The names of individual files should not be longer than 20 -30 characters and the names of folders and subfolders should not be longer than 120 characters.
The requests should be designated as follows in the subject line of the Cover letter and in the COMMENTS field of the CESP submission:
|Category||Sub-Category||Subject line in CESP comments|
|Initial CTA||Initial CTA/EudraCT-No./ Abbreviation study code; VHP-No. if applicable// e.g. iCTA/4998/2020-494949-01|
|response to validation requests||Resp. Val. Req./ Vorlage-No.: / EudraCT-No. // e.g. Resp. Val. Req./4998/2020-494949-01|
|response to address grounds for non-acceptance (GNA)||Resp. GNA/ Vorlage-No.: / EudraCT-No.|
// e.g. Resp.GNA/4998/2020-494949-01
|substantial amendment||Subst. Amend./ Vorlage-Nr.: / EudraCT No. // e.g. SA/4998/2020-494949-01|
|Non substantial amendment||Non – Subst. Amend. / Vorlage-Nr.: / EudraCT No. // e.g. non-SA / 4998 / 2020-494949-01|
|End of Trial or premature end of trial||EOT OR pEOT/ Vorlage-Nr.: / EudraCT No. // e.g. EOT / 4998 / 2020-494949-01|
|summary report - results||Sum. Report/ Vorlage-No.: / EudraCT-No. // e.g. SR/4998/2020-494949-01|
|Annual Safety Report/DSUR||DSUR / DSUR Number; Reporting period; Vorlage-No.: / EudraCT-No., if possible|
|Annual Safety Report/DSUR for several clinical trials||Multi-CT-DSUR; Reporting period;|
|General Information||Gen. Info. / Vorlage-Nr.: / EudraCT No / e.g. GI/4998/2020-494949-01|
|Interruption, Temp Hold, restriction of recruiting, etc||Temp. Hold or Interrup. recruit./ Vorlage-No.: / EudraCT-No. Please choose only one|
|Urgent Safety Measures||USM/ Vorlage-No.: / EudraCT-No. // e.g. USM/4998/2020-494949-01|
|Fulfilment of condition (without additional changes & incl. naming of procedural step)||Fulf. Cond. / Vorlage-No.: / EudraCT-No. // e.g. Fulf. Cond. (SA)/4998/2020-494949-01|
|Objection to decision (incl. naming of procedural step)||Obj. decis. / Vorlage-No.: / EudraCT-No. // e.g. Obj. decis. (SA)/4998/2020-494949-01 or / e.g. Obj. decis. (iCTA)//4998/2020-494949-01|
If you have any questions regarding registration or technical details, please contact the following e-mail address: firstname.lastname@example.org.
For submissions via CESP, parallel sending of CDs or DVDs to the competent authorities is not required.
Please note that the electronic submission option is an alternative to the previous paper submission option.
A written form of submission is therefore not necessary, since according to § 3a Abs. 2 Nr. 1 Alt. 2 VwVfG, authentication is carried out by registration with CESP.
It is, of course, still possible to submit the documents in paper form and on a data carrier such as CD or DVD. The same legal requirements continue to apply to the submission of an application for approval for clinical trials.
Submissions on paper and additional electronic media
Structure of the contents of the electronic data medium
Section 7 (1) of the Ordinance on GCP lays down that applications for the authorisation of a clinical trial must be submitted in a paper version and the application form as well as the documents to be attached must in addition, also be submitted to the federal competent authority on an electronic data carrier.
BfArM and PEI have prepared a submission structure for electronic data carriers (CD-ROM/DVD) designed to harmonise and standardise the submission of applications including the appropriate documentation attached. This structure shows a major similarity to the submission formats of other European authorities. BfArM and PEI are trying their best to push through a uniform European submission format.
Documents for submission
|24.04.2013||Specification for the submission on CD-ROM or DVD|
|24.04.2013||Sample folder for the electronic submission|
|03.04.2020||Details on the electronic clinical trial application via CESP|
The zip archive contains the following folder structure:
In those cases where applicants adhere completely to the specifications of the electronic submission format, the BfArM/PEI renounces the submission of additional paper copies for the application (this means that only one paper copy and the electronic data carrier has to be submitted). For this purpose, the cover letter for the application must contain a note confirming that the application contained in the electronic data carrier and the documents pertaining to it have been submitted in compliance with the currently applicable specifications published on the homepage of the BfArM/PEI and that the electronic version is identical with the original version on paper. If this is the case, the submission of the original of the application bearing the applicant's signature and one electronic data carrier will suffice (This does not mean that the application form is sufficient. A paper copy has to be included in addition to the electronic data carrier.).